NCT03910296

Brief Summary

The purpose of this research study is to develop a psychological treatment for patients with cancer, focused on the psychological symptoms they experience during opioid therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 10, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

May 3, 2022

Status Verified

May 1, 2022

Enrollment Period

2.4 years

First QC Date

April 8, 2019

Last Update Submit

May 2, 2022

Conditions

Cancer

Keywords

Cancer

Outcome Measures

Primary Outcomes (1)

  • Study feasibility

    Defined by participants' completion of 80% of measures

    2 years

Secondary Outcomes (1)

  • Intervention acceptability

    2 years

Study Arms (1)

Acceptance & Commitment Therapy

* Acceptance \& Commitment Therapy (ACT) use acceptance, mindfulness, commitment, and behavior change strategies to increase psychological flexibility. * Each subject will participate for 6 sessions of Acceptance \& Commitment Therapy (ACT). * ACT trains patients to reframe their unpleasant, negative, private events while encouraging personal values.

Behavioral: Acceptance & Commitment Therapy

Interventions

Acceptance & Commitment TherapyBEHAVIORAL

ACT is a unique, third-wave therapy that uses metaphors and experiential exercises to encourage contact with previously avoided thoughts, feelings, and behaviors.

Acceptance & Commitment Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All potentially eligible patients will be identified through the DFCI ambulatory palliative care clinics.

You may qualify if:

  • must be at least 18 years of age
  • speak and comprehend English sufficiently to be able to complete the study procedures and participate in psychotherapy in English
  • have been diagnosed with cancer
  • have an estimated survival time ≥6 months (as approximated by palliative care clinic staff)
  • score ≥4 on the Opioid Risk Tool (Webster \& Webster, 2005) with psychosocial distress as one of the positive items.

You may not qualify if:

  • untreated bipolar disorder
  • untreated psychotic disorders
  • untreated borderline personality disorder
  • have an estimated survival time ≤6 months (as approximated by clinic staff).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Acceptance and Commitment Therapy

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Miryam Yusufov, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 8, 2019

First Posted

April 10, 2019

Study Start

February 20, 2019

Primary Completion

June 30, 2021

Study Completion

July 30, 2021

Last Updated

May 3, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data can be shared no earlier than 1 year following the date of publication
Access Criteria
BCH - Contact the Technology \& Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US(1)