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

NCT02931864 | Completed

• 1 other identifier: R-545-000-073-592
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Change from baseline quality of life score at 8 weeks

  Change between baseline and at 8 weeks

• Change from baseline quality of life score at 12 weeks

  Change between baseline and at 12 weeks

• Change from baseline quality of life score at 24 weeks

  Change between baseline and at 24 weeks

Secondary Outcomes (21)

• Change from baseline social support score at 8 weeks

  Change between baseline and at 8 weeks

• Change from baseline social support score at 12 weeks

  Change between baseline and at 12 weeks

• Change from baseline social support score at 24 weeks

  Change between baseline and at 24 weeks

• Change from baseline self-efficacy score at 8 weeks

  Change between baseline and at 8 weeks

• Change from baseline self-efficacy score at 12 weeks

  Change between baseline and at 12 weeks

Study Arms (4)

Usual care group

NO INTERVENTION

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

Experimental group

EXPERIMENTAL

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

Other: Online mindfulness training; Other: Online symptom management

Comparison group 1

ACTIVE COMPARATOR

Five weekly sessions of online symptom management programme + usual care

Other: Online symptom management

Comparison group 2

ACTIVE COMPARATOR

Five weekly sessions of online mindfulness training programme and usual care

Other: Online mindfulness training

Interventions

Online mindfulness training OTHER

5 weekly sessions of online self-administered mindfulness training programme in which they will receive audio-recorded and video-recorded instructions, pictorial or text-based instructions for various mindfulness exercises such as body scan meditation, mindful breathing and walking meditation.

Comparison group 2; Experimental group

Online symptom management OTHER

5 weekly online education module in which they will receive video-recorded, audio-recorded, pictorial or text-based instructions for various self-management strategies. Topics include fatigue, pain, numbness/tingling, lymphedema, anxiety/depression, and problems with sleeping.

Comparison group 1; Experimental group

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National University of Singapore: lead
• National University Hospital, Singapore: collaborator
• National Cancer Centre, Singapore: collaborator

Study Sites (2)

National Cancer Centre Singapore

Singapore, Singapore

Location

National University Hospital

Singapore, Singapore

Location

Related Publications (7)

• Cheng KK, Darshini Devi R, Wong WH, Koh C. Perceived symptoms and the supportive care needs of breast cancer survivors six months to five years post-treatment period. Eur J Oncol Nurs. 2014 Feb;18(1):3-9. doi: 10.1016/j.ejon.2013.10.005. Epub 2013 Dec 5.

  PMID: 24315730 BACKGROUND

• Ferrell BR, Dow KH, Grant M. Measurement of the quality of life in cancer survivors. Qual Life Res. 1995 Dec;4(6):523-31. doi: 10.1007/BF00634747.

  PMID: 8556012 BACKGROUND

• Portenoy RK, Thaler HT, Kornblith AB, Lepore JM, Friedlander-Klar H, Kiyasu E, Sobel K, Coyle N, Kemeny N, Norton L, et al. The Memorial Symptom Assessment Scale: an instrument for the evaluation of symptom prevalence, characteristics and distress. Eur J Cancer. 1994;30A(9):1326-36. doi: 10.1016/0959-8049(94)90182-1.

  PMID: 7999421 BACKGROUND

• Bower JE, Ganz PA, Desmond KA, Bernaards C, Rowland JH, Meyerowitz BE, Belin TR. Fatigue in long-term breast carcinoma survivors: a longitudinal investigation. Cancer. 2006 Feb 15;106(4):751-8. doi: 10.1002/cncr.21671.

  PMID: 16400678 BACKGROUND

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 BACKGROUND

• Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.

  PMID: 16443717 BACKGROUND

• Champion VL, Ziner KW, Monahan PO, Stump TE, Cella D, Smith LG, Bell CJ, Von Ah D, Sledge GW. Development and psychometric testing of a breast cancer survivor self-efficacy scale. Oncol Nurs Forum. 2013 Nov;40(6):E403-10. doi: 10.1188/13.ONF.E403-E410.

  PMID: 24161644 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• Karis Cheng

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: October 13, 2016
• Study Start: December 6, 2016
• Primary Completion: March 14, 2020
• Study Completion: March 14, 2020
• Last Updated: September 23, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)