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

NCT ID: NCT05765916

Last Updated: 2023-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 244 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2023-12-30

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?

Conditions

Fear of Cancer Recurrence; Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Online mindfulness and acceptance intervention

Participants of the intervention group will receive an intervention manual and videos. The duration of the intervention will be six weeks. Participants will be asked for a minimum time investment of 60 min per week. The intervention will be delivered via WeChat video call. The intervention will be conducted following the intervention manual to ensure consistency of intervention content that delivered.

Group Type: EXPERIMENTAL

Online mindfulness and acceptance intervention

Intervention Type: BEHAVIORAL

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.

Standard of care

Participants of the control group will be received usual follow-up care including regular medical checkups, which may include a physical exam, blood tests, and imaging tests.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National University of Singapore

OTHER

Sponsor Role: lead

Responsible Party

LYU Mengmeng

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rosalind Chiew-Jiat SIAH, Dr

Role: STUDY_DIRECTOR

National University of Singapore

Karis Kin Fong CHENG

Role: STUDY_DIRECTOR

Global Nursing Research Center, Graduate School of Medicine, The University of Tokyo, Japan

Locations

National University of Singapore

Singapore, , Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

Mengmeng Lyu

Role: CONTACT

e0529482@u.nus.edu

+6586577205

Facility Contacts

Mengmeng Lyu

Role: primary

e0529482@u.nus.edu

+6586577205

Other Identifiers

LMengmeng

Identifier Type: -

Identifier Source: org_study_id