An Online Psychosocial Intervention for Fear of Cancer Recurrence in Breast Cancer Survivors
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fear of Cancer Recurrence
- Sponsor
- National University of Singapore
- Enrollment
- 244
- Locations
- 1
- Primary Endpoint
- Fear of cancer recurrence
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
A total of 244 breast cancer survivors will be invited to participate in the randomized controlled trial. Breast cancer survivors who meet the inclusion criteria and provide digital informed consent will be included. Participants will be stratified and randomized by the severity of baseline fear of cancer recurrence and time since diagnosis. In the control arm, women will be treated as usual. In the intervention arm, women will be offered a six-weekly, 60 min, online mindfulness and acceptance intervention. An online questionnaire will be used to collect data at four time points: before the first group session, immediately after the intervention, three months, and six months post-intervention. Phone interviews exploring participants' experiences will be held immediately after the intervention with women of the intervention group.
Detailed Description
The main study is a two-armed RCT with a 1:1 allocation ratio: (1) online psychosocial intervention; and (2) treat as usual. RCT is a gold standard for examining intervention effectiveness as it is the most reliable approach for proving the causal relationships between interventions and changes in outcome variables. Although no separate study can prove causality, randomization can reduce allocation bias stemmed from the differences in baseline variables and provides a rigorous approach for examining causality between interventions and outcome changes. Therefore, this study adopted an RCT design to examine the effectiveness of the psychosocial intervention in reducing FCR. Primary and secondary outcomes were assessed at two time points: before intervention commencement (T0) and immediate post-intervention (T1). Participants' experience in participating in the intervention was explored at the T1 through individual interview via phone call. The magnitude of the effects of the intervention on the primary outcome of FCR and other secondary outcomes will be examined to determine if they were consistent with the existing literature. This study hypothesizes that the online psycho-social intervention will yield larger reductions in FCR and other psychosocial outcomes at post-treatment compared with a standardized care control group receiving formal follow-up care including clinical examination and health education on side-effects managements. Research questions Question 1: Primary outcome Is the online mindfulness and acceptance intervention effective in the reduction of FCR compared with control condition at post-intervention? Question 2: Secondary outcomes Is the online mindfulness and acceptance intervention effective in reducing cognitive avoidance, illness representation, and in enhancing quality of life compared with the control condition? Question 3: Participants' Experience What is the perception of the participants about the impact of the online intervention program on FCR?
Investigators
LYU Mengmeng
Principal Investigator
National University of Singapore
Eligibility Criteria
Inclusion Criteria
- •are over 18 years old
- •diagnosed with primary stage 0-III breast cancer
- •have completed primary cancer treatment within ten years (ongoing endocrine therapy is permitted)
- •have sub-clinical or clinical fear of cancer recurrence as defined by a score in the range of 13 to 21 or \> 21 on the fear of cancer recurrence inventory (FCRI)
- •have a smart-phone
- •can speak and read Mandarin
Exclusion Criteria
- •with cognitive impairment such as diagnosis of Parkinson's disease
- •have clinically diagnosed psychiatric disorder
- •are engaging in mindfulness and acceptance intervention
Outcomes
Primary Outcomes
Fear of cancer recurrence
Time Frame: Change from the baseline FCRI score at six weeks.
The Fear of Cancer Recurrence Inventory (FCRI) is a multidimensional self-reported instrument that assesses participants' experiences of FCR. The FCRI comprises 42 items and seven sub-scales inclusive of triggers, severity, psychological distress, functional impairment, insight, reassurance, and coping strategies. Responses are based on a 5-point Likert scale ranging from 0 (not at all or never) to 4 (a great deal or all the time). A total score can be obtained for each subscale and for the total scale by summing the items. The severity subscale is used to assess the severity of FCR. The sum of the items of severity subscale ranges from 0 to 36. Cut-offs for the severity subscale scores are as follows: nonclinical FCR, less than 13; subclinical FCR, 13 to 21; and clinically significant FCR, more than 21. The reliability and validity of the Chinese version of FCRI have been examined in 297 Chinese BCSs (Cronbach's alpha = 0.912; test-retest reliability = 0.88).
Secondary Outcomes
- Physical, role, emotional, social and cognitive functioning(Change from the baseline physical, role, emotional, social and cognitive functioning at six weeks.)
- Illness representation(Change from the baseline score of BIPQ-R at six weeks.)
- Cognitive avoidance(Change from the baseline score of cognitive avoidance at six weeks.)