An Online Psychosocial Intervention for Fear of Cancer Recurrence in Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

An Online Psychosocial Intervention for Fear of Cancer Recurrence in Breast Cancer Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05765916
• Other study ID #: LMengmeng
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2023
• Source: National University of Singapore
• Contact: Mengmeng Lyu
• Phone: +6586577205
• Email: e0529482[@]u.nus.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Fear of Cancer Recurrence
• Recurrence

Intervention

Behavioral:
• Online mindfulness and acceptance intervention
Session 1 aims to encourage participants to share their experiences; and introduce the purpose, content, delivery mode, duration, and frequency of the intervention. Session 2 aims to explain how negative illness perceptions lead to fear of cancer recurrence; and introduce the signs, screening, treatment and prognosis of breast cancer, ways to reduce the risk of recurrence, and symptom management. Session 3 aims to guide the participants to practice body scan and seated meditation. Session 4 aims to guide the participants to practice detached mindfulness, promoting reflection on the negative effect of indulging in unhelpful thoughts. In session 5, participants will receive several forms covering work, health, parenting style, intimate relationships, self-development and so on. Participant will be asked to choose one or two forms and set action plans. In session 6, the facilitator will invite participants to recall positive experiences and practice the "Self-care" exercise.

Locations

Country	Name	City	State
Singapore	National University of Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University of Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

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.