Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02931864
Other study ID # R-545-000-073-592
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 6, 2016
Est. completion date March 14, 2020

Study information

Verified date September 2020
Source National University, Singapore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 172
Est. completion date March 14, 2020
Est. primary completion date March 14, 2020
Accepts healthy volunteers No
Gender Female
Age group 21 Years to 100 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Online mindfulness training
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.
Online symptom management
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.

Locations

Country Name City State
Singapore National Cancer Centre Singapore Singapore
Singapore National University Hospital Singapore

Sponsors (3)

Lead Sponsor Collaborator
National University, Singapore National Cancer Centre, Singapore, National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Ferrell BR, Dow KH, Grant M. Measurement of the quality of life in cancer survivors. Qual Life Res. 1995 Dec;4(6):523-31. — View Citation

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. — View Citation

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline quality of life score at 8 weeks Change between baseline and at 8 weeks
Primary Change from baseline quality of life score at 12 weeks Change between baseline and at 12 weeks
Primary Change from baseline quality of life score at 24 weeks Change between baseline and at 24 weeks
Secondary Change from baseline social support score at 8 weeks Change between baseline and at 8 weeks
Secondary Change from baseline social support score at 12 weeks Change between baseline and at 12 weeks
Secondary Change from baseline social support score at 24 weeks Change between baseline and at 24 weeks
Secondary Change from baseline self-efficacy score at 8 weeks Change between baseline and at 8 weeks
Secondary Change from baseline self-efficacy score at 12 weeks Change between baseline and at 12 weeks
Secondary Change from baseline self-efficacy score at 24 weeks Change between baseline and at 24 weeks
Secondary Change from baseline symptom score at 8 weeks Change between baseline and at 8 weeks
Secondary Change from baseline symptom score at 12 weeks Change between baseline and at 12 weeks
Secondary Change from baseline symptom score at 24 weeks Change between baseline and at 24 weeks
Secondary Change from baseline psychosocial adjustment to illness score at 8 weeks Change between baseline and at 8 weeks
Secondary Change from baseline psychosocial adjustment to illness score at 12 weeks Change between baseline and at 12 weeks
Secondary Change from baseline psychosocial adjustment to illness score at 24 weeks Change between baseline and at 24 weeks
Secondary Change from baseline fear of recurrence score at 8 weeks Change between baseline and at 8 weeks
Secondary Change from baseline fear of recurrence score at 12 weeks Change between baseline and at 12 weeks
Secondary Change from baseline fear of recurrence score at 24 weeks Change between baseline and at 24 weeks
Secondary Change from baseline anxiety and depression score at 8 weeks Change between baseline and at 8 weeks
Secondary Change from baseline anxiety and depression score at 12 weeks Change between baseline and at 12 weeks
Secondary Change from baseline anxiety and depression score at 24 weeks Change between baseline and at 24 weeks
Secondary Change from baseline mindfulness score at 8 weeks Change between baseline and at 8 weeks
Secondary Change from baseline mindfulness score at 12 weeks Change between baseline and at 12 weeks
Secondary Change from baseline mindfulness score at 24 weeks Change between baseline and at 24 weeks
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Completed NCT06238557 - Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT05472935 - Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers N/A
Recruiting NCT04444544 - Quality of Life and High-Risk Abdominal Cancer Surgery
Completed NCT04281953 - Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
Recruiting NCT05546931 - Mobile Health Program for Rural Hypertension N/A
Active, not recruiting NCT04746664 - Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia N/A
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Recruiting NCT04142827 - The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX) N/A
Active, not recruiting NCT05903638 - A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Completed NCT06216015 - Exercise Training and Kidney Transplantation N/A
Completed NCT03813420 - Sleep Quality of Physiotherapy Students Quality of Life and Physical Activity Level N/A
Recruiting NCT05550545 - Infant RSV Infections and Health-related Quality of Life of Families
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Recruiting NCT05233020 - Robotic Versus Hybrid Assisted Ventral Hernia Repair N/A
Terminated NCT03304184 - The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life Phase 3
Completed NCT05063305 - Probiotics, Immunity, Stress, and QofL N/A
Recruiting NCT05380856 - Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction N/A