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Completed

NCT Number: NCT03910296

Acceptance and Commitment Therapy (ACT) - Based Treatment Development for Cancer Patients Treated for Pain

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

About this study

This research study is a treatment development study, which is the first time investigators are developing this psychological intervention in patients with cancer, on opioid therapy. This study is being conducted to develop a psychological intervention designed specifically for individuals with cancer. The purpose of this study is to determine how practical this intervention is, to determine patient satisfaction, and test the study procedures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Acceptance & Commitment Therapy

Behavioral

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

Primary outcomes

  1. Study feasibility

    Time frame: 2 years

    Defined by participants' completion of 80% of measures

Secondary outcomes

  1. Intervention acceptability

    Time frame: 2 years

    Defined by participant responses on the semi-structured qualitative interviews, upon treatment completion.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 10, 2019
Registry last updated
May 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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