A multimodal couple-coping intervention after treatment for premenopausal breast cancer

Not Applicable

• Conditions: Breast cancer; Cancer

• Registration Number: ISRCTN35481498
• Lead Sponsor: The Chinese University of Hong Kong

Brief Summary

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39172959/ (added 23/08/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-08
• Last Update Posted: 2 September 2024
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

Phase I:
1. Patients: Women with a diagnosis of breast cancer; all active treatment completed but endocrine and/ or maintenance therapy allowed; with a regular sexual partner, either heterosexual or homosexual; over 18 years; in a premenopausal state when diagnosed with breast cancer; has a smartphone with internet connection;
able to understand spoken Cantonese and to read Chinese; consenting to participate.
2. Partners of the participating patients.
3. Academics: Academics who specialise in oncology research from the institute of the PI.
4. Healthcare professionals: Registered nurses and physicians working in the oncology unit of two participating hospitals, with at least two-year clinical experience in the specialty.

Phase II:
1. Patients: Women with a diagnosis of breast cancer; completed active treatment for breast cancer in recent three months but endocrine and/ or maintenance therapy allowed, and with no evidence of metastatic disease; with a regular sexual partner, either heterosexual or homosexual; over 18 years; in a premenopausal state when diagnosed with breast cancer; has a smartphone with internet connection; able to understand spoken Cantonese and to read Chinese; consenting to participate.
2. Partners of the participating patients.

Exclusion Criteria

Phases I & II: Patients with a known pre-existing psychiatric illness will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sexual adjustment will be measured by the Chinese version of the Sexual Adjustment and Body Image Scale (SABIS) at baseline (T0), on completion of the intervention (T1) and 3 months post-intervention (T2). [Phase II]

Secondary Outcome Measures

Name	Time	Method
1. Relationship quality will be measured by the Chinese version of the ENRICH Marital Satisfaction Scale (EMS) at baseline (T0), on completion of the intervention (T1) and 3 months post-intervention (T2). [Phase II]<br>2. Quality of life will be measured by the Chinese version of MOS 36-item Short Form version 2 (SF-36v2®) Health Survey at baseline (T0), on completion of the intervention (T1) and 3 months post-intervention (T2). [Phase II]<br>3. Intervention participants and their' experiences, perceptions and opinions will be explored by semi-structured interviews upon completion of the intervention. [Phases I & II]<br>4. Expert's comments and suggestions on the intervention will be explored by semi-structured interviews. [Phase I]