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

NCT06906575 | Not Yet Recruiting

• 1 other identifier: 2024-749
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sexual Dysfunction, Psychological; Relationship Distress; Cancer

Outcome Measures

Primary Outcomes (2)

• Sexual and Relationship Distress

  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

  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 Outcomes (3)

• Body Image

  3 months after intervention

• Psychological Flexibility

  3 months after intervention

• Dyadic Coping

  3 months after intervention

Study Arms (1)

Walking Together with Love

EXPERIMENTAL

Behavioral: A Comprehensive Intervention to Improve Sexual and Relationship Well-being for Cancer Patients and Their Partners

Interventions

A Comprehensive Intervention to Improve Sexual and Relationship Well-being for Cancer Patients and Their Partners BEHAVIORAL

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.

Walking Together with Love

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Yanfei Jin: lead

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological; Neoplasms

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Yanfei Jin

CONTACT

16672040891; alisaflower@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nanjing Medical University

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 2, 2025
• Study Start: April 1, 2025
• Primary Completion: October 26, 2025
• Study Completion: October 26, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share