Breast Cancer Clinical Trial
Official title:
An Online Psychosocial Intervention for Fear of Cancer Recurrence in Breast Cancer Survivors
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.
Status | Recruiting |
Enrollment | 244 |
Est. completion date | December 30, 2023 |
Est. primary completion date | July 30, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Singapore | National University of Singapore | Singapore |
Lead Sponsor | Collaborator |
---|---|
National University of Singapore |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fear of cancer recurrence | 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). | Change from the baseline FCRI score at six weeks. | |
Secondary | Illness representation | Brief Illness Perception Questionnaire-Revised (BIPQ-R) is a nine-item self-reported instrument. Five of the items assess cognitive illness representations: consequences (Item 1), timeline (Item 2), personal control (Item 3), treatment control (Item 4), and identity (Item 5). Two of the items assess emotional representations: concern (Item 6) and emotions (Item 8). One item assesses illness comprehensibility (Item 7). Responses are based on a 10-point Likert scale ranging from 0 (no at all) to 10 (extremely concerned). A total score can be obtained for each subscale and for the total scale by summing the items, with higher scores indicating more negative illness perceptions. Causal representations were assessed with an open-ended response item adapted from the IPQ-R that asked patients to list the three most important causal factors in their disease (item 9). The Cronbach's alpha values of the scale was 0.77 and the split-half reliability was 0.81. | Change from the baseline score of BIPQ-R at six weeks. | |
Secondary | Cognitive avoidance | The Impact of Event Scale (IES) is a self-administered questionnaire that designed to tap into the two most common patterns of psychological reactions associated with trauma, namely intrusiveness (individuals involuntarily has those images, thoughts, nightmares, and feelings about the traumatic events) and avoidance (individuals intentionally do not want to think or talk about the traumatic event and all matters related to it). Weiss and Marmar added six items to the IES that measured emotional arousal - certain intrusive images and thoughts that provoke anxiety and worry - to develop a 22-item IES-R. Each item was measured using 5-point Likert scales, with higher mean scores on each subscale indicate greater avoidance/intrusiveness/arousal. In this study only avoidance subscale was used. The Chinese version IES-R subscales have good internal consistency (Cronbach's a = .83-.89). | Change from the baseline score of cognitive avoidance at six weeks. | |
Secondary | Physical, role, emotional, social and cognitive functioning | The European Organization for Research and Treatment-QOL breast cancer specific module (EORTC QOL-BR23): The 23-item EORTC QLQ-BR23 is composed of 5 dimensions to evaluate systemic therapy side effects, arm symptoms, breast symptoms, body image, and sexual functioning; 3 independent items assess sexual enjoyment, feeling of upset due to hair loss, and future perspective. These 23 items are rated on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much). Responses are based on the frequency of cancer-related symptoms or distress an individual has experienced in the past week. The initial scale has demonstrated acceptable to good internal consistency (Cronbach's alpha = 0.52 to 0.89) and moderate to strong test-retest reliability (Pearson correlations ranging from 0.54 to 0.63). The reliability of the Chinese version of the EORTC QLQ-BR53 has been examined in Chinese cancer patients (Cronbach's alpha = 0.615 to 0.923). | Change from the baseline physical, role, emotional, social and cognitive functioning at six weeks. |
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