Acceptance and Commitment Therapy on Fatigue Interference in Patients With Advanced Lung Cancer and Caregiver Burden (ACT)

NCT05885984 | Unknown

• 1 other identifier: CREC Ref. No. 2023.030
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Lung cancer is a malignant tumour that has transformed from a single cancer disease into one of the most striking global health problems. Lung cancer has an insidious onset, and most patients are first diagnosed with the middle and advanced stages. Cancer-related fatigue is the most common and distressing symptom reported by lung cancer patients. For cancer patients, fatigue has a lasting impact on physical, psychological and social functions, and interferes with activities and participating in life events, thereby worsening the health-related quality of life. Family members have a key role in providing advanced lung cancer patients with informational, instrumental, and emotional support, which is crucial to patients' adaptation to the advanced illness and living a meaningful cancer life. Acceptance and Commitment Therapy (ACT) is the third-wave cognitive behavioural therapy to improve functioning and health-related quality of life by increasing psychological flexibility. The study aims to examine test the feasibility and acceptability, and preliminary effects of online ACT on fatigue interference in patients with advanced lung cancer and caregiver burden.

Conditions

Lung Cancer; Advanced Cancer; Caregiver Burden

Keywords

lung cancer; palliative care; Acceptance and Commitment Therapy; cancer-related fatigue; caregiver burden

Outcome Measures

Primary Outcomes (6)

• Eligibility rate

  The eligiblity rate is defined as the percentage of participants fulfilling the inclusion criteria amongst the participants screened for the eligibility

  Before baseline

• Recruimtment rate

  The recruitment rate is defined as the percentage of participants who consented to participate in the study amongst the participants eligible for the study

  Before baseline

• Attrition rate

  The attrition rate is defined as the percentage of participants who withdrew from the study before completion

  After the 6-week intervention

• Adherence rate

  The adherence rate is defined as the frequency of the practice of mindfulness and session attendance

  After the 6-week intervention

• Change from baseline in the score of fatigue interference assessed by The Fatigue Symptom Inventory at one week after the intervention

  A 13-item instrument that measures the intensity and interference of fatigue over the previous 7 days. The first four items are used to assess the intensity of fatigue, Item 5 - Item 11 are to assess the degree to which fatigue in the past week was judged to interfere with different aspects, such as general activity, bathe and dress ability, work activity, concentration ability, relation with others, enjoyment of life and mood, using a 11-point Likert scale ranging from 0 (no interference) to 10 (extreme interference). 0 indicates no fatigue and 127 indicates the worst fatigue intensity and interference.

  Baseline (T0) and post-intervention (T1, one week after the 6-week intervention)

• Change from baseline in the score of caregiver burden assessed by The Zarit Caregiver Burden Inventory at one week after the intervention

  12 items score from 1(not always) to 5 (always) to assess caregiver burdens of caregivers of advanced lung cancer patients, including three domains: role strain, self-criticism, and negative emotion. The overall score can be obtained by adding all subscale scores. 12 indicates low caregiver burden and 60 indicates the highest caregiver burden.

  Baseline (T0) and post-intervention (T1, one week after the 6-week intervention)

Secondary Outcomes (4)

• Change from baseline in the score of health-related quality of life assessed by Functional Assessment of Cancer Therapy - Lung, Version 4 at one week after the intervention

  Baseline (T0) and post-intervention (T1, one week after the 6-week intervention)

• Change from baseline in the score of meanfing of life assessed by The Meaning of Life questionnaire (MLQ) at one week after the intervention

  Baseline (T0) and post-intervention (T1, one week after the 6-week intervention)

• Change from baseline in the score of psychological flexibility assessed by Comprehensive assessment of Acceptance and Commitment Therapy processes at three months after the intervention

  Baseline (T0) and post-intervention (T1, one week after the 6-week intervention)

• Change from baseline in the score of mindful attention assessed by Mindful Attention Awareness Scale at one week after the intervention

  Baseline (T0) and post-intervention (T1, one week after the 6-week intervention)

Other Outcomes (1)

• Acceptability of the intervention

  After the 6-week intervention

Study Arms (2)

ACT group

EXPERIMENTAL

Participants in the intervention group will receive ACT intervention, consisting of six online sessions via video conferencing platform (The first two sessions for patient only, the third and fourth sessions for caregiver only, and the last two sessions for patient-caregiver dyads) of 60-90 min each (once/week), in addition to health education.

Behavioral: Acceptance and Commitment Therapy (ACT) plus health education

Health eduction control group

OTHER

Participants randomised to the health education control group will receive six weekly health education by a video-conferencing platform. The topics mainly include treatments and daily care during admission, medication instructions and side effects, diet and exercise advice, and retest recommendations when discharged.

Other: Health education

Interventions

Acceptance and Commitment Therapy (ACT) plus health education BEHAVIORAL

Session 1: Reviewing experiences on struggles with CRF, realising consequence of controlling, introducing acceptance as an alternative, adopting virtual mindfulness. Education (patient): epidemiologic features of advanced lung cancer. Session 2: Separate thoughts/feelings related to CRF. Education (patient): treatments and symptoms of advanced lung cancer. Session 3: Reviewing caregiver's experiences of struggling with caregiving burden,introducing acceptance as an alternative. Education (caregiver): epidemiologic features of advanced lung cancer. Session 4: Separate caregivers' thoughts/feelings related to caregiving burden. Education (caregiver): treatments and symptoms of advanced lung cancer. Session 5:Understand the importance of values and clarifying personal values for dyads. Education (dyads): eating suggestions. Session 6: Emphasise ongoing value-based goals and commitment to actions for a meaningful cancer life for dyads. Education (dyads): exercising suggestions.

ACT group

Health education OTHER

Session 1: health education on the epidemiologic features of advanced lung cancer will be taught to patients. Session 2: health education on treatments and related symptoms of advanced lung cancer will be taught to patients. Session 3: health education on the epidemiologic features of advanced lung cancer will be taught to caregivers. Session 4: health education on treatments and related symptoms of advanced lung cancer will be taught to caregivers. Session 5: health education on eating suggestions for advanced lung cancer patients and caregivers will be taught. Session 6: health education on exercising suggestions for advanced lung cancer patients and caregivers will be taught.

Health eduction control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 or over;
• diagnosed with stage III or stage IV lung cancer by pathological section or cytology;
• lived in rural areas;
• experienced unexplained fatigue syndrome: the score of 3 or more on the Fatigue Symptom Inventory (FSI);
• able to provide informed consent and effectively collect data;
• a consenting primary family caregiver; and
• working phone service

You may not qualify if:

• diagnosed with cognitive dysfunction or other mental illnesses that may interfere with their completion of treatment;
• who are at critical condition; and
• who are receiving or have just completed other lung cancer-related intervention programs within the last six months

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Association for contextual behavioral science: collaborator

Study Sites (1)

Xiangya Hospital Central South University

Changsha, Hunan, China

Location

Related Publications (1)

• Li H, Wong CL, Jin X, Wang N, Shi Z. Effects of acceptance and commitment therapy on fatigue interference in patients with advanced lung cancer and caregiving burden: protocol for a pilot randomised controlled trial. BMJ Open. 2024 Jul 23;14(7):e082090. doi: 10.1136/bmjopen-2023-082090.

  PMID: 39043593 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Caregiver Burden

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Cho Lee WONG, PhD

  The Nethersole School of Nursing, Chinese University of Hong Kong

  STUDY DIRECTOR

• Huiyuan LI, PhD

  The Nethersole School of Nursing, Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huiyuan LI, PhD

CONTACT

52665977; huiyuanli@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor who is independent of the research will be trained before formally conducting data collecting.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are assigned to two groups in parallel for the duration of the study. Participants in Group A receive Acceptance and Commitment Therapy in addition to health education. Participants in Group B receive health education.

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 2, 2023
• Study Start: July 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: January 1, 2024
• Last Updated: June 2, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)