Acceptance and Commitment Therapy in Patients With Advanced Lung Cancer

NCT04869267 | Completed

• 1 other identifier: CREC Ref. No. 2020.581
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Lung cancer is a malignant tumor 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 stage. Cancer related fatigue is the most common and distressing symptom reported by lung cancer patients. For cancer patients, fatigue has lasting impact on physical, psychological and social functions, interferes with activities and participating in life events, thereby worsening the health-related quality of life. Acceptance and Commitment Therapy (ACT) is the third-wave cognitive behavioral therapy to improve functioning and health-related quality of life by increasing psychological flexibility. The study aims to examine the effectiveness of ACT on fatigue interference and health-related quality of life in patients with advanced lung cancer.

Conditions

Lung Cancer; Advanced Cancer

Keywords

lung cancer; palliative care; Acceptance and Commitment Therapy; fatigue; health-related quality of life

Outcome Measures

Primary Outcomes (4)

• 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. Change= (One week after the intervention score - Baseline score)

  Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)

• Change from baseline in the score of the score of fatigue interference assessed by The Fatigue Symptom Inventory at three months after the 4-week 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. Change= (Three months after the intervention score - Baseline score)

  Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)

• 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

  36 items scored from 0 (not at all) to 4 (very much) to assess QoL of lung cancer patients, including 5 domains: physical, social/family, emotional, and functional well-being, and additional concerns about lung cancer. The overall score can be obtained by adding all subscale scores. 0 indicates no quality of life and 144 indicates the highest quality of life. Change= (One week after the intervention score - Baseline score)

  Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)

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

  36 items scored from 0 (not at all) to 4 (very much) to assess QoL of lung cancer patients, including 5 domains: physical, social/family, emotional, and functional well-being, and additional concerns about lung cancer. The overall score can be obtained by adding all subscale scores. 0 indicates no quality of life and 144 indicates the highest quality of life. Change= (Three months after the intervention score - Baseline score)

  Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)

Secondary Outcomes (16)

• Change from baseline in the score of cancer related fatigue assessed by The Multidimensional Fatigue Inventory at one week after the intervention

  Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)

• Change from baseline in the score of cancer related fatigue assessed by The Multidimensional Fatigue Inventory at three months after the intervention

  Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)

• Change from baseline in the score of depressive symptoms assessed by The Patient Health Questionnaire (PHQ-9) at one week after the intervention.

  Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)

• Change from baseline in the score of depressive symptoms assessed by The Patient Health Questionnaire (PHQ-9) at three months after the intervention.

  Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)

• Change from baseline in the score of anxiety assessed by Generalized Anxiety Disorder Scale (GAD-7) at one week after the intervention.

  Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)

Study Arms (2)

ACT group

EXPERIMENTAL

Participants in the intervention group will receive ACT intervention, consisting of four individual sessions (First session by face to face, the last three sessions by Wechat) of 60-90 min each (once/week), in addition to usual care.

Behavioral: Acceptance and Commitment Therapy (ACT)

Usual care group

OTHER

Participants randomized to the control group will receive usual care, including treatments and daily care during admission, medication instructions, diet and exercise advice, retest recommendations when discharge.

Other: Usual care

Interventions

Acceptance and Commitment Therapy (ACT) BEHAVIORAL

Session 1: This session aims to let the participants get familiar with the interventionist. The interventionist will tell them the purpose of the program and basic rules. And the interventionist will promise their privacy protection. Session 2: This session includes how to separate thoughts/feelings/sensations related to diagnose with advanced lung cancer and experience of fatigue with facts and see these feelings in an objective way with observing self. Session 3: This session mainly aims to help participants understand the importance of values, differentiate values from goals and clarify their personal values. Session 4: This session aims at helping patients practice to engaging in committed action based on chosen values, motivated to change behavior in consistency with life direction and health goal.

ACT group

Usual care OTHER

The usual care mainly includes treatments and daily care during admission, medication instructions, diet and exercise advice, retest recommendations when discharge

Usual care 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;
• experienced unexplained fatigue syndrome: the score of 3 or more on the Fatigue Symptom Inventory (FSI); and
• able to provide informed consent and effectively collect data.

You may not qualify if:

• diagnosed with cognitive dysfunction or other mental illnesses that may interfere with their completion of treatment;
• who are with a life expectancy \<3 months, or whose physical conditions are considered ineligible for the present study based on the physician's judgment; 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

Study Sites (1)

Xiangya Hospital Central South University

Changsha, Hunan, China

Location

MeSH Terms

Conditions

Lung Neoplasms; Fatigue

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Huiyuan LI

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

• Cho Lee Wong, PhD

  Chinese University of Hong Kong

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessors who are independent with 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 based on usual care. Participants in Group B receive usual care.

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 3, 2021
• Study Start: July 1, 2021
• Primary Completion: January 7, 2022
• Study Completion: January 7, 2022
• Last Updated: October 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)