Caring for the Sexual Health and Wellbeing of Cancer Survivors and Their Intimate Partners: An Anonymous Survey

October 6, 2023 updated by: Bournemouth University

An Anonymous Survey Investigating Care for the Sexual Health of Cancer Survivors and Their Intimate Partners, as Provided by the United Kingdom Hospital Cancer Team

The aim of this survey study is to provide broad information as reported by cancer survivors and their intimate partners about both their sexual health and their experiences of care from the United Kingdom hospital cancer team, including their perspectives on factors that may hinder or help care. This information will be analysed and used to inform the questions asked in a separate, subsequent, qualitative study.

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.

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.
Observational

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.
169

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

  • United Kingdom
    • Dorset
      • Bournemouth, Dorset, United Kingdom, BH8 8AJ
        • Bournemouth University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

People with cancer or the partners of people with cancer

Description

Inclusion Criteria:

  1. Cancer survivors diagnosed with any type of cancer at age 18 years or over
  2. A partner of someone diagnosed with any type of cancer at age 18 years or over
  3. Cancer diagnosis must be no more than 10 years ago
  4. Cancer survivors or their partners who experienced treatment and follow up care in the United Kingdom

Exclusion Criteria:

  1. Cancer survivors who were diagnosed with cancer below the age of 18 years
  2. Partners of cancer survivors who were diagnosed with cancer below the age of 18 years
  3. Cancer diagnosis was more than 10 years ago
  4. Cancer survivors/partners of survivors where the cancer treatment and follow up was not in the United Kingdom
  5. Previous completion of the survey

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
People with Cancer
No intervention
Other: No intervention
No intervention
Partners of People with Cancer
No intervention
Other: No intervention
No intervention

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
Number of participants who had a sexual health discussion(s) with the hospital cancer team at any point during cancer care
Time Frame: Up to 10 years prior to completing survey (discussion(s) about sexual health could have occurred at any point during cancer care)
Sexual health discussion:19 examples of the sort of topics that may have been discussed in relation to sexual health
Up to 10 years prior to completing survey (discussion(s) about sexual health could have occurred at any point during cancer care)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with specific levels of impact on their sex lives by cancer and its treatments
Time Frame: From each individual participants' cancer diagnosis/cancer treatment until the date that they completed the survey
As above
From each individual participants' cancer diagnosis/cancer treatment until the date that they completed the survey
Survey questionnaire to measure the nature and prevalence of care for sexual health that cancer survivors and their intimate partners self-report experiencing from the UK hospital cancer team.
Time Frame: Participants can report care received from prior to their cancer treatment through to their follow-up care (last 10 years only)
An online survey questionnaire (no validated questionnaire available and therefore research created the questionnaire based on a literature reviews on sexual health in oncology
Participants can report care received from prior to their cancer treatment through to their follow-up care (last 10 years only)
Survey questionnaire to measure the nature and prevalence of the perceived barriers to and facilitators for care for sexual health as received by cancer survivors and their intimate partners when provided by the UK hospital cancer team.
Time Frame: Participants can report their perceptions from diagnosis through to their follow-up care (last 10 years only)
As above
Participants can report their perceptions from diagnosis through to their follow-up care (last 10 years only)
Survey questionnaire to measure to what extent groups of cancer survivors and their intimate partners with differing characteristics receive differing care for their sexual health from the UK hospital cancer team.
Time Frame: Participants diagnosed with cancer in the previous 10 years.
Participants' responses from outcomes 1-4 will be used toinform this outcome
Participants diagnosed with cancer in the previous 10 years.

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.
Bournemouth University

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.
Dorset County Hospital NHS Foundation Trust
National Institute for Health Research, Applied Research Collaboration, Wessex
Fortuneswell Cancer Trust

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.
  • Principal Investigator: Sam Porter, PhD, RN, Bournemouth University

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.
August 23, 2022

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.
September 30, 2022

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.
September 30, 2022

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).
August 3, 2023

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.
October 6, 2023

First Posted (Estimated)

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.
October 10, 2023

Study Record Updates

Last Update Posted (Estimated)

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.
October 10, 2023

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.
October 6, 2023

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.
October 1, 2023

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.
  • Ethics ID 39453

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participant information sheet stated that information would not be made publicly available via a data sharing repository. This approach was taken due to the sensitive nature of the topic and was anticipated to provide reassurance and potentially improve recruitment.

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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