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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

120

Phase

  • 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

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
Intervention / Treatment
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

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

Erla Kolbrún Svavarsdóttir

Collaborators

Landspitali University Hospital

Investigators

  • 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)

April 15, 2017

Primary Completion (Actual)

August 20, 2019

Study Completion (Actual)

August 20, 2019

Study Registration Dates

First Submitted

April 10, 2019

First Submitted That Met QC Criteria

April 30, 2019

First Posted (Actual)

May 3, 2019

Study Record Updates

Last Update Posted (Actual)

November 22, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID 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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