Development of Therapeutic Conversations With Females Diagnosed With Cancer and Their Partners

November 21, 2019 updated by: Erla Kolbrún Svavarsdóttir

Development of Therapeutic Conversations With Females Diagnosed With Cancer and Their Partners: Evaluation of Effectiveness in Adjustment of Sexuality and Intimacy

The main purpose of the doctoral study is to better understand the experience of cancer diagnosis and treatment in how it effects sexuality and intimacy of the female cancer patient and her partner.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

With this increased understanding, an intervention, comprised of therapeutic interventions with the couple, will be conducted and assessed on how it affects the couple's general well-being and recovery of the sexual and intimate relationship.

The intervention consists of three therapeutic conversations, based on the Illness Beliefs model in family nursing, and an optional web-based evidence based information. The aim of the intervention is to support the facilitating beliefs of the couple in adapting to changes in intimacy and identify constraining beliefs. In the first session an emphasis is on creating an optimal context for changing beliefs by building good therapeutic relationship and to invite them to share their experience, giving them the opportunity to voice their own concerns and reflect on how their situation effects their intimate relationship. In the second session, the couple take a closer look at what they themselves deem important in adjusting to changes in their intimate relationship. In both sessions information about the possible sexual side effects of treatment will be offered as needed and evidence based, optional web-based information on practical solutions will be provided. In the booster-session, the couple will assess how they have been adjusting in their intimate relationship and any positive changes that have occurred will be accentuated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iceland
      • Reykjavík, Iceland, 101
        • University of Iceland, School of Health Sciences, Faculty of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All females, 18 yrs and older, diagnosed with cancer (all types) and their partners
  • Have began cancer treatment (surgical treatment, chemotherapy, radiation) - Are in a couple relationship
  • Live in Iceland and are able to travel to site of intervention
  • Speak and write Icelandic

Exclusion Criteria:

  • Single females
  • Do not read or write nor speak Icelandic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Randomized controlled trial
Experimental group receiving a couple-based intervention
Behavioral: Couple-based intervention and and evaluation of effectiveness in increasing adjustment of sexuality and intimacy
Three face-to-face therapeutic conversations and an optional web-based evidence based information (about sexual consequences of cancer treatment)
Active Comparator: Active comparator: control group
A control group that receives same but delayed couple-based intervention
Behavioral: Couple-based intervention and and evaluation of effectiveness in increasing adjustment of sexuality and intimacy
Three face-to-face therapeutic conversations and an optional web-based evidence based information (about sexual consequences of cancer treatment)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) at baseline in experimental group (T1).
Time Frame: T1 ( at baseline).
This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
T1 ( at baseline).
Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) post-intervention in experimental group (T2).
Time Frame: T2 (1-2 weeks after baseline).
This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
T2 (1-2 weeks after baseline).
Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) post-intervention in experimental group (T3).
Time Frame: T3 (3 months after baseline).
This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
T3 (3 months after baseline).
Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) at baseline in control group (T1).
Time Frame: T1 (at baseline).
This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
T1 (at baseline).
Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) pre-intervention in control group (T2).
Time Frame: T2 (wait-pre-intervention, 1 month after baseline).
This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
T2 (wait-pre-intervention, 1 month after baseline).
Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) post-intervention in control group (T3).
Time Frame: T3 (post-intervention, 1-2 weeks from T2).
This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
T3 (post-intervention, 1-2 weeks from T2).
Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) post-intervention in control group (T4).
Time Frame: T4 (post-intervention, 3 months from T3).
This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
T4 (post-intervention, 3 months from T3).
Partnership Questionnaire (PFB; Partnerschaftsfragebogen) at baseline in experimental group (T1).
Time Frame: T1 (at baseline).
This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
T1 (at baseline).
Partnership Questionnaire (PFB; Partnerschaftsfragebogen) post-intervention in experimental group (T2).
Time Frame: T2 (1-2 weeks after baseline).
This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
T2 (1-2 weeks after baseline).
Partnership Questionnaire (PFB; Partnerschaftsfragebogen) post-intervention in experimental group (T3).
Time Frame: T3 (3 months after baseline).
This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
T3 (3 months after baseline).
Partnership Questionnaire (PFB; Partnerschaftsfragebogen) at baseline in control group (T1).
Time Frame: T1 (at baseline).
This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
T1 (at baseline).
Partnership Questionnaire (PFB; Partnerschaftsfragebogen) pre-intervention in control group (T2).
Time Frame: T2 (wait-pre-intervention, 1 month after baseline).
This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
T2 (wait-pre-intervention, 1 month after baseline).
Partnership Questionnaire (PFB; Partnerschaftsfragebogen) post-intervention in control group (T3).
Time Frame: T3 (post-intervention, 1-2 weeks from T2).
This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
T3 (post-intervention, 1-2 weeks from T2).
Partnership Questionnaire (PFB; Partnerschaftsfragebogen) post-intervention in control group (T4).
Time Frame: T4 (post-intervention, 3 months from T3).
This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
T4 (post-intervention, 3 months from T3).
ICE-Beliefs questionnaire for couples (ICE-COUPLE) at baseline in experimental group (T1).
Time Frame: T1 ( at baseline).
The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
T1 ( at baseline).
ICE-Beliefs questionnaire for couples (ICE-COUPLE) post-intervention in experimental group (T2).
Time Frame: T2 (1-2 weeks after baseline).
he instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
T2 (1-2 weeks after baseline).
ICE-Beliefs questionnaire for couples (ICE-COUPLE) post-intervention in experimental group (T3).
Time Frame: T3 (3 months after baseline).
The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
T3 (3 months after baseline).
ICE-Beliefs questionnaire for couples (ICE-COUPLE) at baseline in control group (T1).
Time Frame: T1 (at baseline).
The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
T1 (at baseline).
ICE-Beliefs questionnaire for couples (ICE-COUPLE) pre-intervention in control group (T2).
Time Frame: T2 (wait-pre-intervention, 1 month after baseline).
The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
T2 (wait-pre-intervention, 1 month after baseline).
ICE-Beliefs questionnaire for couples (ICE-COUPLE) post-intervention in control group (T3).
Time Frame: T3 (post-intervention, 1-2 weeks from T2).
The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
T3 (post-intervention, 1-2 weeks from T2).
ICE-Beliefs questionnaire for couples (ICE-COUPLE) post-intervention in control group (T4).
Time Frame: T4 (post-intervention, 3 months from T3).
The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
T4 (post-intervention, 3 months from T3).
The Illness Intrusiveness Rating Scale (IIRS) at baseline in experimental group (T1).
Time Frame: T1 ( at baseline).
Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
T1 ( at baseline).
The Illness Intrusiveness Rating Scale (IIRS) post-intervention in experimental group (T2).
Time Frame: T2 (1-2 weeks after baseline).
Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
T2 (1-2 weeks after baseline).
The Illness Intrusiveness Rating Scale (IIRS) post-intervention in experimental group (T3).
Time Frame: T3 (3 months after baseline).
Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
T3 (3 months after baseline).
The Illness Intrusiveness Rating Scale (IIRS) at baseline in control group (T1).
Time Frame: T1 (at baseline).
Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
T1 (at baseline).
The Illness Intrusiveness Rating Scale (IIRS) pre-intervention in control group (T2).
Time Frame: T2 (wait-pre-intervention, 1 month after baseline).
Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
T2 (wait-pre-intervention, 1 month after baseline).
The Illness Intrusiveness Rating Scale (IIRS) post-intervention in control group (T3).
Time Frame: T3 (post-intervention, 1-2 weeks from T2).
Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
T3 (post-intervention, 1-2 weeks from T2).
The Illness Intrusiveness Rating Scale (IIRS) post-intervention in control group (T4).
Time Frame: T4 (post-intervention, 3 months from T3).
Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
T4 (post-intervention, 3 months from T3).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Erla Kolbrún Svavarsdóttir

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Landspitali University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ása Þórisdóttir, PhD, University of Iceland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 20, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 20, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UIceland-22019JIJ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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