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Lung CancerNCT05885984

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

A study testing Acceptance and Commitment Therapy (ACT) plus health education and Health education in people with Lung Cancer and Advanced Cancer, run by Chinese University of Hong Kong at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Advanced Cancer, Caregiver Burden
What is being tested?
Acceptance and Commitment Therapy (ACT) plus health education and Health education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
Jul 2023to Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Huiyuan LI, PhD contact

52665977

huiyuanli@cuhk.edu.hk

China1 site

  • Xiangya Hospital Central South University

    Changsha, Hunan

    Nina WANG, Master, +86 13974897928, w.nn@qq.com

Other trials in China

About this study

Official title: Effects of Acceptance and Commitment Therapy on Fatigue Interference in Patients With Advanced Lung Cancer and Caregiver Burden: A Pilot Randomised Controlled Trial

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.

Read the detailed description

A two-arm, assessor-blind randomised controlled trial will be conducted to investigate the effects of ACT on advanced lung cancer patients and caregivers compared to educational control. Participants in the same ward will be randomised at a 1:1 ratio to the intervention group or control group. Block randomization will be conducted by an independent research assistant using randomly varying block sizes of 4 and 6 to avoid selection bias. The study aims to examine the feasibility and acceptability, and preliminary effects of online ACT on fatigue interference in patients with advanced lung cancer and caregiver burden. The Specific objectives are:

  1. To investigate the feasibility and acceptability of the online 6-week ACT in patients with advanced lung cancer and caregivers in rural areas in China;
  2. To investigate the preliminary effects of the online 6-week ACT in patients with advanced lung cancer and caregivers in rural areas in China;
  3. To explore how patients and caregivers perceive the ACT experience during the intervention process.
Being tested
Acceptance and Commitment Therapy (ACT) plus health education, Health education
Keywords
lung cancer, palliative care, Acceptance and Commitment Therapy, cancer-related fatigue, caregiver burden
Medical subject headings
Lung Neoplasms, Caregiver Burden

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acceptance and Commitment Therapy (ACT) plus health educationBehavioural

    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.

  • Health educationOther

    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.

Study groups in NCT05885984
Study groupRoleWhat they receive
ACT groupExperimentalParticipants 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.
Receives: Behavioral: Acceptance and Commitment Therapy (ACT) plus health education
Health eduction control groupOtherParticipants 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.
Receives: Other: Health education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Eligibility rate

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

    Measured: Before baseline

  2. 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

    Measured: Before baseline

  3. Attrition rate

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

    Measured: After the 6-week intervention

  4. Adherence rate

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

    Measured: After the 6-week intervention

  5. 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.

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

  6. 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.

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

Secondary outcomes (4)

  1. 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)

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

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

    8 items score from 0 (not at all) to 7 (totall agree) to assess meaning of life of caregivers of advanced lung cancer patients, including 2 domains: the Presence of Meaning subscale and the Search for Meaning subscale. The overall score can be obtained by adding all subscale scores. 0 indicates no meaning of life and 56 indicates the highest meaning of life.

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

  3. 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

    A comprehensive ACT process measure to evaluate the level of psychological flexibility (and constituent sub-process) within the ACT model with 18 items ranged from 18 to 90. 18 indicates low level of psychological flexibility and 90 indicates the high level of psychological flexibility.

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

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

    The trait MAAS is a 15-item scale designed to assess a core characteristic of mindfulness, scored from 1 (almost never) to 6 (almost always). 15 indicates low level of awareness and attention to present moment and 90 indicates the high level of awareness and attention to the present moment.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2023
  2. Study startJul 2023 (estimated)
  3. Primary completionNov 2023 (estimated)
  4. Study completionJan 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05885984
Sponsor's protocol ID
CREC Ref. No. 2023.030
Status last verified
May 2023
First submitted
23 May 2023
Last updated
2 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39043593

Questions about this trial

What is this clinical trial studying?

A study testing Acceptance and Commitment Therapy (ACT) plus health education and Health education in people with Lung Cancer and Advanced Cancer, run by Chinese University of Hong Kong at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Huiyuan LI, PhD (52665977, huiyuanli@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Eligibility rate (time frame: Before baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05885984, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.

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