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Gastrointestinal NeoplasmsNCT04010227

Telephone Support for Advanced Gastrointestinal Cancer Patients and Caregivers

A study testing Acceptance and Commitment Therapy and Education/Support in people with Gastrointestinal Neoplasms, run by Indiana University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial tests telephone-based Acceptance and Commitment Therapy (ACT), a type of psychotherapy, to reduce fatigue interference with activities, mood, and cognition in advanced gastrointestinal (GI) cancer patients and family caregiver burden. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastrointestinal Neoplasms
What is being tested?
Acceptance and Commitment Therapy and Education/Support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
2 sitesUnited States
Study dates
16 Sep 2019to 8 Jun 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Patient Inclusion Criteria:

  • Patient is at least 3 weeks post-diagnosis of unresectable stage III or stage IV gastrointestinal cancer (i.e., anal, colon, esophageal, gallbladder, liver, pancreatic, rectal, small intestine, or stomach cancer) and is receiving care at the Indiana University Simon Cancer Center or Eskenazi Health.
  • Patient is at least 21 years of age.
  • Patient can speak and read English.
  • Patient has an eligible, consenting family caregiver (see criteria below).
  • Patient has moderate to severe fatigue interference with functioning.

Patient Exclusion Criteria:

  • Patient shows significant psychiatric or cognitive impairment that would preclude providing informed consent and study participation.
  • Patient reports being able to do little activity on a functional status measure.
  • Patient is receiving hospice care at screening.
  • Patient does not have working phone service.
  • Patient has hearing impairment that precludes participation.

Caregiver Inclusion Criteria:

  • Family caregiver identified by a stage IV gastrointestinal cancer patient who meets the eligibility criteria.
  • Caregiver has significant caregiving burden or distress
  • Caregiver lives with the patient or has visited the patient in-person at least twice a week for the past month.
  • Caregiver is at least 18 years of age.
  • Caregiver can speak and read English.

Caregiver Exclusion Criteria:

  • Caregiver shows significant psychiatric or cognitive impairment that would preclude providing informed consent and study participation.
  • Caregiver does not have working phone service.
  • Caregiver has hearing impairment that precludes participation.
  • Patient declines study participation.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Eskenazi Health

    Indianapolis, Indiana, 46202

  • Indiana University Simon Comprehensive Cancer Center

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: Telephone Support for Advanced Gastrointestinal Cancer Patients and Their Family Caregivers

This trial tests telephone-based Acceptance and Commitment Therapy (ACT), a type of psychotherapy, to reduce fatigue interference with activities, mood, and cognition in advanced gastrointestinal (GI) cancer patients and family caregiver burden. ACT includes mindfulness exercises (e.g., meditations, performing activities with greater awareness), identifying personal values (e.g., family, spirituality), and engaging in activities consistent with these values. A total of 40 patient-caregiver dyads were randomly assigned in equal numbers to either the ACT intervention or an education/support condition. Dyads in both conditions participated in six weekly 50-minute telephone sessions. Outcomes were assessed at baseline, 2 weeks post-intervention, and 3 months post-intervention. The investigators hypothesize that ACT will lead to improved primary and secondary outcomes as compared to education/support. Study findings will inform a large-scale trial of intervention efficacy.

Read the detailed description

This trial evaluates the feasibility, acceptability, and preliminary efficacy of telephone-based Acceptance and Commitment Therapy (ACT) on fatigue interference in advanced gastrointestinal (GI) cancer patients and family caregiver burden as well as secondary outcomes. The study team recruited advanced GI cancer patients receiving care at the Indiana University Simon Cancer Center or Eskenazi Health hospital. Potentially eligible patients were mailed an introductory letter signed by their oncologist and the PI along with a consent form. The letter had a number to call if they did not wish to be contacted further. A research assistant (RA) called all prospective participants who did not opt out approximately 1 to 2 weeks after the letter was mailed. The RA described the study as outlined in the consent form and answered any questions. Then the RA administered an eligibility screening to those who consented to participate. Eligible and consenting patients identified a potentially eligible family caregiver. If the family caregiver was eligible and consented to participate, then the patient and caregiver each completed a baseline phone assessment. Following baseline assessments, patient-caregiver dyads (N = 40 dyads) were randomly assigned in equal numbers to ACT or education/support using a stratified block randomization scheme to balance the groups by patient performance status (patient-reported Eastern Cooperative Oncology Group [ECOG] scores 0 or 1 vs. 2). Dyads in both study conditions completed six weekly 50-minute telephone sessions with the first session occurring one week after baseline. For ACT participants, adherence to home practice during the past week was assessed and recorded during each session. Feasibility will be examined via accrual, attrition, and adherence rates, and acceptability will be evaluated using a mixed methods approach (qualitative and quantitative). Blind interviewers assessed outcomes during follow-up phone assessments at 2 weeks and 3 months post-intervention.

Being tested
Acceptance and Commitment Therapy, Education/Support
Keywords
Acceptance and Commitment Therapy, Fatigue, Family Caregivers, Psychotherapy
Medical subject headings
Gastrointestinal Neoplasms, Fatigue

What participants receive

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

  • Acceptance and Commitment TherapyBehavioural

    Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers practice various mindfulness exercises, clarify their values, and set specific goals in alignment with their values. Through in-session and home practice of skills, participants learn new and more adaptive ways to respond to unwanted internal experiences (e.g., fatigue, distress). Participants receive handouts on session topics and a compact disc (CD) that we developed to guide mindfulness practices.

  • Education/SupportBehavioural

    Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers are directed to resources for practical and health information and contact information for psychosocial services. Sessions include an orientation to the patient's medical center and treatment team, education regarding common quality-of-life concerns experienced by cancer patients and caregivers, and an overview of medical center and community resources for addressing these concerns. The therapist also describes resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants receive handouts summarizing session topics and are asked to review them as homework.

Study groups in NCT04010227
Study groupRoleWhat they receive
Acceptance and Commitment TherapyExperimentalPatients and caregivers in the ACT arm learn new and more adaptive ways to respond to difficult internal experiences (e.g., fatigue, thoughts, and feelings).
Receives: Behavioral: Acceptance and Commitment Therapy
Education/SupportActive comparatorPatients and caregivers in the education/support arm discuss their cancer-related concerns and receive education on services available in their medical center and community.
Receives: Behavioral: Education/Support

What is being measured

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

  1. Fatigue Interference Subscale of Fatigue Symptom Inventory

    Seven items are rated on 11-point scales (0=no interference to 10=extreme interference) that assess the extent to which fatigue in the past week interfered with general level of activity, ability to bathe and dress, normal work activity (including housework), ability to concentrate, relations with others, enjoyment of life, and mood. The seven items are summed with higher total scores indicating greater fatigue interference. The total score range is 0 to 70. This is the primary outcome for patients.

    Measured: 2 weeks and 3 months post-intervention

  2. Short-form of Zarit Burden Interview

    Twelve items are rated on 5-point scales (0=never to 4=nearly always) that assess personal strain and role strain due to caregiving. The 12 items are summed with higher total scores indicating greater caregiving burden. The total score range is 0 to 48. This is the primary outcome for caregivers.

    Measured: 2 weeks and 3 months post-intervention

Secondary outcomes (6)

  1. Patient-Reported Outcome Measurement Information System (PROMIS) Sleep-Related Impairment

    This 8-item measure assesses the perceived interference of sleep problems with activities, mood, and cognition (e.g., difficulty concentrating or completing tasks). Each item is rated on a scale from 1 (not at all) to 5 (very much). Item #2 is reverse-scored and then the 8 items are summed with higher total scores indicating greater sleep-related impairment. The total scores are converted to T-scores with a range from 30.0 to 80.1. Higher T-scores indicate a worse outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome for patients.

    Measured: 2 weeks and 3 months post-intervention

  2. PROMIS Ability to Participate in Social Roles and Activities

    This 6-item measure assesses participants' ability to participate in social roles and activities. The items measure difficulty engaging in social and recreational activities as well as usual work (including housework). Each item is rated on a scale from 1 (never) to 5 (always) and is reverse coded. Then the six items are summed with higher total scores indicating greater ability to participate in social roles and activities. The total scores are converted to T-scores with a range from 26.7 to 65.0 with higher scores indicating a better outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome for both patients and caregivers.

    Measured: 2 weeks and 3 months post-intervention

  3. Acceptance and Action Questionnaire-II

    This 7-item measure assesses psychological flexibility, or the ability to fully experience the present moment while persisting in actions aligned with personal values. Each item is rated on a scale from 1 (never true) to 7 (always true). The seven items are summed with higher total scores indicating greater levels of psychological inflexibility. The total score range is 7 to 49. This is a secondary outcome for both patients and caregivers.

    Measured: 2 weeks and 3 months post-intervention

  4. McGill Quality of Life Questionnaire-Revised

    This 15-item measure evaluates physical, psychological, existential, and social quality of life in patients with serious illnesses. Each of the 4 subscale scores (i.e., physical, psychological, existential, and social quality of life) is the sum of the items with higher scores indicating better quality of life. Items are rated on 0 to 10 scales. The physical quality of life subscale is the sum of 3 items (2 items reverse-coded) with a range of 0 to 30. The psychological quality of life subscale is the sum of 4 items (all items reverse-coded) with a range of 0 to 40. The existential quality of life subscale is the sum of 4 items (1 item reverse-coded) with a range of 0 to 40. The social quality of life subscale is the sum of 3 items (none reverse-coded) with a range of 0 to 30. This is a secondary outcome measure for patients.

    Measured: 2 weeks and 3 months post-intervention

  5. PROMIS Global Health

    This 10-item measure assesses global health, including physical, mental, and social well-being. With the exception of pain, which is rated on a 0 to 10 scale, all items are rated on 5-point scales from 1 to 5. The item on pain is recoded from a 0-10 to a 1-5 scale and reverse-scored. Two additional items are reverse-scored. Then four of the items are summed, with higher physical quality of life subscale scores indicating better physical quality of life. Four other items are also summed with higher psychological quality of life subscale scores indicating better psychological quality of life. The subscale scores are converted to T-scores with a range from 16.2 to 67.7 for physical quality of life and a range from 21.2 to 67.6 for psychological quality of life. Higher T-scores for the physical and psychological quality of life subscales indicate a better outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome measure for caregivers.

    Measured: 2 weeks and 3 months post-intervention

  6. Value Progress Subscale of the Valuing Questionnaire.

    This 5-item subscale assesses progress in living according to one's personal values, a construct related to activity engagement. Items are rated on 0 to 6 scales. The 5 items are summed with higher total subscale scores indicating greater progress in living according to one's personal values. The total subscale score range is 0 to 30. This is a secondary outcome measure for patients and caregivers.

    Measured: 2 weeks and 3 months post-intervention

Timeline

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

  1. First posted8 Jul 2019
  2. Study start16 Sep 2019
  3. Primary completion8 Jun 2021
  4. Study completion8 Jun 2021

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
Advanced gastrointestinal cancer patient-family caregiver dyads (N = 40) were randomly assigned in equal numbers to Acceptance and Commitment Therapy (ACT) or education/support using a stratified block randomization scheme to balance the groups by patient performance status (patient-reported Eastern Cooperative Oncology Group \[ECOG\] scores 0 or 1 vs. 2).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04010227
Sponsor's protocol ID
1904388865
Other IDs
R21CA235788
Status last verified
Nov 2022
First submitted
3 Jul 2019
Last updated
22 Dec 2022
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Results of this trial will be presented at professional meetings and published in peer-reviewed journals. The data set will be made available to qualified investigators within 6 months of the publication of the primary outcome paper. The data set will contain necessary identifiers, excluding those prohibited by HIPAA. The investigators will be required to sign a data use agreement and obtain Institutional Review Board (IRB) approval before receiving the data set.

Publications

  • Mosher CE, Secinti E, Kroenke K, Helft PR, Turk AA, Loehrer PJ Sr, Sehdev A, Al-Hader AA, Champion VL, Johns SA. Acceptance and commitment therapy for fatigue interference in advanced gastrointestinal cancer and caregiver burden: protocol of a pilot randomized controlled trial. Pilot Feasibility Stud. 2021 Apr 20;7(1):99. doi: 10.1186/s40814-021-00837-9.

    PubMed 33879253

  • Mosher CE, Secinti E, Wu W, Kashy DA, Kroenke K, Bricker JB, Helft PR, Turk AA, Loehrer PJ, Sehdev A, Al-Hader AA, Champion VL, Johns SA. Acceptance and commitment therapy for patient fatigue interference and caregiver burden in advanced gastrointestinal cancer: Results of a pilot randomized trial. Palliat Med. 2022 Jul;36(7):1104-1117. doi: 10.1177/02692163221099610. Epub 2022 May 30.

    PubMed 35637615

Questions about this trial

What is this clinical trial studying?

A study testing Acceptance and Commitment Therapy and Education/Support in people with Gastrointestinal Neoplasms, run by Indiana University at 2 sites in United States.

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

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

Yes. Results are posted in the registry (first posted 22 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fatigue Interference Subscale of Fatigue Symptom Inventory (time frame: 2 weeks and 3 months post-intervention). The study lists 2 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 NCT04010227, which also lists 2 linked publications.

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 22 Dec 2022.

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