Effects of an e-Home Based Symptom Management and Mindfulness Training Programme on QoL in Breast Cancer Survivors

National University of Singapore

Status: Completed

Conditions: Oncology; Quality of Life; Breast Cancer Survivors; Symptom Management; Mindfulness Based Cognitive Therapy

Treatments: Other: Online symptom management; Other: Online mindfulness training

Study type: Interventional

Funder types: Other

Identifiers

NCT02931864

R-545-000-073-592

Details and patient eligibility

About

Breast cancer is the most common cancer in women in Singapore. Breast cancer survivors usually experience side effects/symptoms after surgery and/or adjuvant chemotherapy and/or radiotherapy such as fatigue, lymphedema, problems with sleeping, peripheral neuropathy, and anxiety/depression. Currently, there is no study to include both symptom management and mindfulness training components for breast cancer survivors. And given breast cancer survivors have infrequent clinical follow-up, we aim to develop an e-Home based symptom management and mindfulness training programme for breast cancer survivors and to determine its effects on quality of life, symptom distress, psychosocial adjustment, psychological morbidity, and unplanned outpatient attendance or hospitalisation in breast cancer survivors. We employ a randomised clinical trial with four study arms (with 47 subjects in each arm) together with a process evaluation; group 1 (usual care), group 2 (experimental group: five weekly sessions of online symptom management + mindfulness training programme and usual care), group 3 (comparison group 1: five weekly sessions of online symptom management programme and usual care), and group 4 (comparison group 2: five weekly sessions of online mindfulness training programme and usual care). Subjects will complete questionnaires measures of 6-item Social Support Questionnaire, Breast Cancer Survivor Self-Efficacy Scale, the Quality of Life-Cancer Survivor Scale, Memorial Symptom Assessment Scale, Psychosocial Adjustment to Illness Scale, short version of the Fear of Recurrence Scale, Hospital and anxiety Depression Scale and Five Facet Mindfulness Questionnaire at baseline (printed questionnaires), at 8 weeks from baseline, at 12 weeks from baseline and at 24 weeks from baseline by an online system or printed questionnaires. Individualised semi-structured interview (15-25 mins) for experimental and comparison groups will be conducted at 24 weeks from baseline to understand the subjects' experiences of the study programme. Data will be analysed using SPSS version 24. Baseline demographic and clinical information of subjects in the experimental, comparison and control groups will be summarised using descriptive statistics, and will be compared using chi square tests and ANOVA/ANCOVA tests. Intention-to-treat approach will be used. Repeated measures analysis of variance will be used to examine the differences on outcome measures among the experimental, comparison and control groups across study time points. In addition, differences in changes in outcome measures among experimental, comparison groups and usual care groups will be tested using multilevel modelling techniques. A p-value smaller than 5% will be considered as statistically significant. Content analysis will be conducted to analyse the interviews data.

Enrollment: 172 patients

Sex: Female

Ages: 21 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women aged 21 or above
• able to speak and read English
• diagnosed with breast cancer stage 0 to 3 for the first time
• have completed cancer treatment including breast surgery and/or adjuvant chemotherapy and/or radiotherapy between 6 months to 5 years previously
• with and without ongoing HER2 target therapy (e.g.: Herceptin) and/or hormonal therapy
• with ECOG Performance Status score of 0 to 1
• able to understand the study and give informed consent
• have access to the internet through a handheld device

Exclusion criteria

• they are illiterate
• have serious psychiatric disorders (e.g. schizophrenia, dementia, and intellectual disabilities)
• with ECOG Performance Status score of 2 or above

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

172 participants in 4 patient groups

Usual care group

No Intervention group

Description:

Usual care is meant the routine medical and health care services at the hospital.

Experimental group

Experimental group

Description:

Five weekly sessions of online symptom management + mindfulness training programme + usual care

Treatment:

Other: Online symptom management

Other: Online mindfulness training

Comparison group 1

Active Comparator group

Description:

Five weekly sessions of online symptom management programme + usual care

Treatment:

Other: Online symptom management

Comparison group 2

Active Comparator group

Description:

Five weekly sessions of online mindfulness training programme and usual care

Treatment:

Other: Online mindfulness training