"Walking Together with Love": a Couples-Based Intervention for Sexual and Relationship Distress in Cancer Patients (WTL)

March 25, 2025 updated by: Yanfei Jin

"Walking Together with Love": a Comprehensive Intervention Targeting Body Image, Psychological Flexibility, and Dyadic Coping for Sexual and Relationship Distress Among Cancer Patients and Their Partners

Cancer diagnosis and treatment often result in significant changes in body appearance, sexual functioning, and relationship quality, leading to distress for both patients and their partners. To address these challenges, a comprehensive intervention program called "Walking Together with Love" (WTL) has been developed.

This intervention focuses on three key areas: improving body image (supporting patients in accepting physical changes after cancer treatment), enhancing psychological flexibility (enabling patients and partners to openly and positively manage difficult experiences), and strengthening dyadic coping skills (promoting effective communication and emotional support between partners). The primary aim of this intervention is to reduce sexual and relationship distress among cancer patients and their partners.

WTL is a six-week program consisting of weekly 90- to 120-minute sessions delivered in a hybrid format (both online and offline). Sessions incorporate psychoeducational presentations, group discussions, professional guidance, and structured home assignments. Both patients and their partners participate together, collaboratively working toward improving relationship quality and overall well-being.

Cancer patients, their partners, and healthcare providers are encouraged to learn more about this research project and explore its potential benefits in improving quality of life for couples affected by cancer.

Study Overview

Detailed Description

Cancer diagnosis and treatment frequently lead to multiple physical, psychological, and interpersonal challenges. Among these, disruptions in body image, sexual functioning, and relationship dynamics are particularly common and distressing for both patients and their intimate partners. Existing evidence suggests that difficulties in accepting body changes, reduced psychological flexibility, and inadequate dyadic coping strategies significantly contribute to sexual and relationship distress among couples facing cancer.

To address these unmet needs, a couples-based intervention called "Walking Together with Love" (WTL) has been developed. Grounded in cognitive behavioral therapy (CBT), acceptance and commitment therapy (ACT), and dyadic coping theory, this intervention integrates three core therapeutic components:

Body Image Improvement:

Supports cancer patients and their partners in understanding and accepting physical changes resulting from cancer treatments.

Fosters positive attitudes toward body image and self-esteem.

Psychological Flexibility Enhancement:

Utilizes ACT-based strategies to improve participants' ability to acknowledge and adaptively manage difficult emotions, thoughts, and experiences related to cancer diagnosis and treatment.

Dyadic Coping Skill Training:

Provides systematic skill-building exercises designed to strengthen mutual support mechanisms, enhance effective communication, and promote collaborative problem-solving when facing cancer-related stressors.

The WTL intervention is delivered in a structured, interactive, and collaborative manner, specifically designed to support both patients and their partners.

Program Duration and Format:

A six-week structured intervention program, with weekly sessions lasting approximately 90-120 minutes.

Sessions are delivered in a hybrid format (virtual and in-person) to maximize accessibility and convenience.

Session Content and Methods:

Each session incorporates psychoeducational presentations, guided discussions, experiential exercises, and structured home assignments.

Core areas covered include managing body image concerns, cultivating psychological flexibility, enhancing intimacy and communication skills, and reinforcing collaborative coping strategies.

Participant Involvement:

Both cancer patients and their intimate partners actively engage in all sessions, participating in therapeutic tasks and home assignments.

This collaborative approach fosters mutual understanding, emotional closeness, and relationship resilience.

Evaluation and Outcome Measures:

To assess the effectiveness of the intervention, multiple time-point assessments will be conducted (pre-intervention baseline, post-intervention, and follow-up assessments).

Outcome measures include sexual and relationship distress, body image acceptance, psychological flexibility, relationship quality, and overall well-being, assessed using validated psychometric instruments.

The primary goal of the WTL intervention is to provide a practical, evidence-based, and scalable approach to alleviating sexual and relationship distress among cancer patients and their intimate partners. By addressing psychological and relational challenges, this intervention aims to enhance quality of life and psychosocial adjustment to cancer.

Study Type

Interventional

Enrollment (Estimated)

100

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 Contact

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Diagnosed with cancer, with a duration of at least 3 months after surgery; Aged 18-49 and married; were able to complete the questionnaire independently; were willing to participate.

Exclusion Criteria: cognitive or psychiatric impairments and suffering from severe heart, liver, kidney, and other serious complications.

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Walking Together with Love

This intervention targets three core areas:

Body Image Improvement - Supports patients in understanding and accepting physical changes resulting from cancer treatments, fostering positive attitudes toward body image and self-esteem.

Psychological Flexibility Enhancement - Utilizes ACT-based strategies to help participants acknowledge and adaptively manage difficult emotions, thoughts, and experiences related to cancer diagnosis and treatment.

Dyadic Coping Skill Training - Provides structured skill-building exercises to strengthen mutual support mechanisms, enhance effective partner communication, and promote collaborative problem-solving when facing cancer-related stressors.

The intervention consists of six weekly sessions (90-120 minutes each), delivered in a hybrid format (virtual and in-person) to maximize accessibility. Each session integrates psychoeducational presentations, facilitated discussions, guided experiential exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sexual and Relationship Distress
Time Frame: 3 months after intervention
The Sexual and Relationship Distress Scale (SaRDS) is used to measured the Sexual and Relationship Distress .The SaRDS is a 30-item, 14-factor patient-reported outcome measure of individual and relationship distress within the context of sexual dysfunction14. All items are rated on a 7-point Likert scale ("not at all true" to "completely true"). The total scores range from 0 to 180 and reflect the standard of individual and relationship distress within the context of sexual dysfunction, with high values indicating more distress. In the original version of the study, the SaRDS showed good psychometric properties, and the subsequent studies also reported the strong internal consistency of the SaRDS (Cronbach alpha = .95 for the total score with individual sub-scales ranging from .70-.96).
3 months after intervention
Relationship Satisfaction
Time Frame: 3 months after intervention
The Couples Satisfaction Index (CSI-16) is a validated measure of relationship satisfaction, assessing perceived intimacy, emotional closeness, and overall satisfaction within the relationship. Higher scores indicate greater relationship satisfaction.
3 months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Image
Time Frame: 3 months after intervention
The Body Image Scale (BIS) will be used to assess body image concerns among cancer patients. The BIS is a validated 10-item self-report questionnaire designed to evaluate body image distress, self-consciousness, and changes in body perception following cancer treatment. Higher scores indicate greater body image disturbance.
3 months after intervention
Psychological Flexibility
Time Frame: 3 months after intervention
Measurement Tool: The Acceptance and Action Questionnaire-II (AAQ-II) will be used to assess psychological flexibility. The AAQ-II is a validated 7-item self-report measure that evaluates experiential avoidance and the ability to accept thoughts and emotions while engaging in values-based actions. Higher scores indicate greater psychological inflexibility, while lower scores reflect higher psychological flexibility.
3 months after intervention
Dyadic Coping
Time Frame: 3 months after intervention
Measurement Tool: The Dyadic Coping Inventory (DCI) will be used to assess dyadic coping strategies among cancer patients and their partners. The DCI is a validated self-report questionnaire that evaluates how partners support each other in managing stress, communicate emotions, and engage in joint coping efforts. Higher scores indicate more effective dyadic coping and greater relationship resilience.
3 months after intervention

Collaborators and Investigators

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

Sponsor

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 (Estimated)

April 1, 2025

Primary Completion (Estimated)

October 26, 2025

Study Completion (Estimated)

October 26, 2025

Study Registration Dates

First Submitted

March 24, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

April 2, 2025

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-749 (Registry Identifier: Nanjing Medical University Ethics Committee)

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

product manufactured in and exported from the U.S.

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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