NCT04010227

Telephone Support for Advanced Gastrointestinal Cancer Patients and Caregivers

Completed NA Results posted Last updated 22 December 2022

What this trial tests

NA trial testing Acceptance and Commitment Therapy in Gastrointestinal Neoplasms in 84 participants. Completed in 8 June 2021.

Timeline

16 September 2019

Primary endpoint
8 June 2021

8 June 2021

Quick facts

Lead sponsor	Indiana University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	84
Start date	16 September 2019
Primary completion	8 June 2021
Estimated completion	8 June 2021
Sites	2 locations across United States

Drugs / interventions tested

• Acceptance and Commitment Therapy
• Education/Support

Conditions studied

• Gastrointestinal Neoplasms — all drugs for Gastrointestinal Neoplasms →

Sponsor

Indiana University

Who can join

18 and older, any sex, with Gastrointestinal Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Fatigue Interference Subscale of Fatigue Symptom Inventory Primary · 2 weeks and 3 months post-intervention

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.

Patient fatigue interference at 2 weeks post-intervention

Group	Value	95% CI
Acceptance and Commitment Therapy	3.93	± 2.17
Education/Support	3.47	± 2.54

Patient fatigue interference at 3 months post-intervention

Group	Value	95% CI
Acceptance and Commitment Therapy	4.27	± 1.66
Education/Support	4.26	± 2.12

Short-form of Zarit Burden Interview Primary · 2 weeks and 3 months post-intervention

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.

Caregiver burden at 2 weeks post-intervention

Group	Value	95% CI
Acceptance and Commitment Therapy	13.92	± 3.86
Education/Support	16.37	± 7.10

Caregiver burden at 3 months post-intervention

Group	Value	95% CI
Acceptance and Commitment Therapy	15.32	± 4.59
Education/Support	18.17	± 8.36

Patient-Reported Outcome Measurement Information System (PROMIS) Sleep-Related Impairment Secondary · 2 weeks and 3 months post-intervention

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.

Patient sleep-related impairment at 2 weeks post-intervention

Group	Value	95% CI
Acceptance and Commitment Therapy	57.37	± 4.03
Education/Support	52.99	± 8.38

Patient sleep-related impairment at 3 months post-intervention

Group	Value	95% CI
Acceptance and Commitment Therapy	56.91	± 5.22
Education/Support	53.86	± 7.41

PROMIS Ability to Participate in Social Roles and Activities Secondary · 2 weeks and 3 months post-intervention

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 sta

Patient ability to participate in social roles and activities at 2 weeks post-intervention

Group	Value	95% CI
Acceptance and Commitment Therapy	45.02	± 6.60
Education/Support	42.42	± 7.26

Patient ability to participate in social roles and activities at 3 months post-intervention

Group	Value	95% CI
Acceptance and Commitment Therapy	45.58	± 6.92
Education/Support	46.14	± 5.01

Caregiver ability to participate in social roles and activities at 2 weeks post-intervention

Group	Value	95% CI
Acceptance and Commitment Therapy	42.56	± 4.66
Education/Support	40.40	± 7.05

Caregiver ability to participate in social roles and activities at 3 months post-intervention

Group	Value	95% CI
Acceptance and Commitment Therapy	40.34	± 2.62
Education/Support	41.04	± 8.11

Acceptance and Action Questionnaire-II Secondary · 2 weeks and 3 months post-intervention

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.

Patient psychological inflexibility at 2 weeks post-intervention

Group	Value	95% CI
Acceptance and Commitment Therapy	13.82	± 4.98
Education/Support	14.52	± 6.45

Patient psychological inflexibility at 3 months post-intervention

Group	Value	95% CI
Acceptance and Commitment Therapy	13.85	± 6.04
Education/Support	15.97	± 5.61

Caregiver psychological inflexibility at 2 weeks post-intervention

Group	Value	95% CI
Acceptance and Commitment Therapy	17.77	± 6.45
Education/Support	17.45	± 8.22

Caregiver psychological inflexibility at 3 months post-intervention

Group	Value	95% CI
Acceptance and Commitment Therapy	17.58	± 6.21
Education/Support	17.79	± 6.41

McGill Quality of Life Questionnaire-Revised Secondary · 2 weeks and 3 months post-intervention

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

Patient physical quality of life at 2 weeks post-intervention

Group	Value	95% CI
Acceptance and Commitment Therapy	17.30	± 6.34
Education/Support	16.89	± 6.20

Patient physical quality of life at 3 months post-intervention

Group	Value	95% CI
Acceptance and Commitment Therapy	13.48	± 5.40
Education/Support	14.80	± 6.33

Patient psychological quality of life at 2 weeks post-intervention

Group	Value	95% CI
Acceptance and Commitment Therapy	28.58	± 8.31
Education/Support	29.98	± 5.99

Patient psychological quality of life at 3 months post-intervention

Group	Value	95% CI
Acceptance and Commitment Therapy	28.66	± 8.36
Education/Support	26.09	± 8.27

Patient existential quality of life at 2 weeks post-intervention

Group	Value	95% CI
Acceptance and Commitment Therapy	28.18	± 5.35
Education/Support	28.15	± 5.06

Patient existential quality of life at 3 months post-intervention

Group	Value	95% CI
Acceptance and Commitment Therapy	28.25	± 4.57
Education/Support	27.15	± 4.83

Patient social quality of life at 2 weeks post-intervention

Group	Value	95% CI
Acceptance and Commitment Therapy	24.59	± 5.18
Education/Support	24.80	± 5.32

Patient social quality of life at 3 months post-intervention

Group	Value	95% CI
Acceptance and Commitment Therapy	25.28	± 4.30
Education/Support	25.64	± 3.51

PROMIS Global Health Secondary · 2 weeks and 3 months post-intervention

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. Th

Caregiver physical quality of life at 2 weeks post-intervention

Group	Value	95% CI
Acceptance and Commitment Therapy	46.11	± 6.02
Education/Support	45.34	± 5.24

Caregiver physical quality of life at 3 months post-intervention

Group	Value	95% CI
Acceptance and Commitment Therapy	45.58	± 4.42
Education/Support	44.68	± 3.33

Caregiver psychological quality of life at 2 weeks post-intervention

Group	Value	95% CI
Acceptance and Commitment Therapy	45.01	± 5.11
Education/Support	43.48	± 7.48

Caregiver psychological quality of life at 3 months post-intervention

Group	Value	95% CI
Acceptance and Commitment Therapy	43.99	± 4.50
Education/Support	43.30	± 5.90

Value Progress Subscale of the Valuing Questionnaire. Secondary · 2 weeks and 3 months post-intervention

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.

Patient values progress at 2 weeks post-intervention

Group	Value	95% CI
Acceptance and Commitment Therapy	21.71	± 3.49
Education/Support	21.30	± 5.29

Patient values progress at 3 months post-intervention

Group	Value	95% CI
Acceptance and Commitment Therapy	22.71	± 3.26
Education/Support	21.66	± 5.09

Caregiver values progress at 2 weeks post-intervention

Group	Value	95% CI
Acceptance and Commitment Therapy	23.05	± 5.39
Education/Support	21.14	± 4.33

Caregiver values progress at 3 months post-intervention

Group	Value	95% CI
Acceptance and Commitment Therapy	22.97	± 2.62
Education/Support	22.44	± 3.05

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected on each participant from the point of baseline until 21 weeks post-baseline.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Acceptance and Commitment Therapy

Serious: 1/20 (5%)

Deaths: 1/20

Education/Support

Serious: 2/20 (10%)

Deaths: 2/20

Before Randomization

Serious: 1/22 (5%)

Deaths: 1/22

Serious adverse events (1 terms)

Reaction	System	Acceptance and Commitment …	Education/Support	Before Randomization
Deaths	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—

Most-reported serious reactions: Deaths.

Data from ClinicalTrials.gov NCT04010227 adverse events section.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Acceptance and commitment therapy for patient fatigue interference and caregiver burden in advanced gastrointestinal cancer: Results of a pilot randomized trial.
   Mosher CE, Secinti E, Wu W, Kashy DA, et al · · 2022 · cited 21× · PMID 35637615 · DOI 10.1177/02692163221099610
2. Acceptance and commitment therapy for fatigue interference in advanced gastrointestinal cancer and caregiver burden: protocol of a pilot randomized controlled trial.
   Mosher CE, Secinti E, Kroenke K, Helft PR, et al · · 2021 · cited 8× · PMID 33879253 · DOI 10.1186/s40814-021-00837-9
3. Impact of acceptance and commitment therapy on physical and psychological symptoms in advanced gastrointestinal cancer patients and caregivers: Secondary results of a pilot randomized trial.
   Burns MF, Secinti E, Johns SA, Wu W, et al · · 2023 · cited 6× · PMID 37064761 · DOI 10.1016/j.jcbs.2023.01.001
4. Application of acceptance and commitment therapy in cancer-related fatigue management: insights from clinical trials and future perspectives.
   Chen X, Li Z. · · 2025 · cited 1× · PMID 39964319 · DOI 10.1097/js9.0000000000002305
5. Acceptance and commitment therapy in metastatic gastrointestinal cancer: patient and caregiver qualitative study.
   Mosher CE, Lewson AB, Austin-Wright M, Matthias MS, et al · · 2025 · PMID 40345850 · DOI 10.1136/spcare-2025-005548