Breast cancer Cancer
Conditions
Interventions
This study consists of two phases:
Phase I of the study aims to explore the acceptability and relevance of the MCI from the perspective of Hong Kong premenopausal women treated for breast cancer and
Phase II of the study aims to evaluate the effects of the MCI on sexual adjustment among premenopausal women treated for breast cancer, and relationship quality and quality of life among the women and
Sponsors
The Chinese University of Hong Kong
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 11/09/2024: 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 six 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. _____ Previous 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
Exclusion criteria: Phases I & II: Patients with a known pre-existing psychiatric illness will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 11/09/2024: 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), 3 months post-intervention (T2) and 6 months post-intervention (T3). [Phase II] _____ Previous primary outcome measure: 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
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 11/09/2024: 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), 3 months post-intervention (T2) and 6 months post-intervention (T3). [Phase II] 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), 3 months post-intervention (T2) and 6 months post-intervention (T3). [Phase II] 3. Intervention participants and their' experiences, perceptions and opinions will be explored by semi-structured interviews upon completion of the intervention. [Phases I & II] 4. Expert's comments and suggestions on the intervention will be explored by semi-structured interviews. [Phase I] _____ Previous secondary outcome measures: 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] 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] 3. Intervention participants and their' experiences, perceptions and opinions will be explored by semi-structured interviews upon completion of the intervention. [Phases I & II] 4. Expert's comments and suggestions on the intervention will be explored by semi-structured interviews. [Phase I] | — |
Countries
Hong Kong
Outcome results
None listed