Pre-consultation Compassion Among Patients Referred to a Cancer Center

NCT04503681 | Completed Results

• 1 other identifier: 20-009
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 1

Brief Summary

Patients diagnosed with cancer commonly have a high degree of anxiety during an initial oncology consultation, which may interfere with a patient's ability to retain information required to make informed treatment decisions. A previous study randomized breast cancer survivors (volunteers) to view either (a) a brief video depicting a standard initial consultation from an oncologist or (b) an identical consultation with the addition of compassionate statements from the oncologist, and found the compassionate statements reduced anxiety among the volunteers. However, it is currently unknown if watching a video containing compassionate statements from an oncologist prior to an actual initial oncology consultation will reduce anxiety among patients referred to a cancer center. The aim of this randomized control trial is to test if watching a brief video containing compassionate statements from an oncologist, compared to watching a standard introduction video, prior to an initial oncology consultation will reduce the degree of anxiety among patients referred to a cancer center. This is a prospective, randomized controlled clinical trial at an academic cancer center. The investigators will enroll adult patients scheduled for an initial oncology consultation. Subjects will be randomly assigned to receive a "standard introduction video" or "enhanced compassion video" for viewing prior to the initial oncology consultation. On arrival to the cancer center anxiety severity will be measured using the Hospital Anxiety and Depression scale (HADS). The HADS has two 7-item subscales (HADS Anxiety and HADS Depression) and is well-validated among oncology patients. Wilcoxon rank-sum test will be used to test for a difference in the HADS subscales between the two video groups.

Conditions

Cancer; Anxiety; Compassion; Empathy

Outcome Measures

Primary Outcomes (1)

• Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS)

  Seven item subscale. Each item is scored on a 4-point scale (0=not at all to 3=nearly all the time); thus, range from 0-21. Higher score indicates greater anxiety.

  Baseline (on arrival to the cancer center for an initial oncology consultant).

Secondary Outcomes (1)

• Depression Subscale of the Hospital Anxiety and Depression Scale

  Baseline (on arrival to the cancer center for an initial oncology consultant).

Study Arms (2)

Standard introduction video

ACTIVE COMPARATOR

Other: Standard introduction video

Enhanced compassion video

EXPERIMENTAL

Other: Enhanced compassion video

Interventions

Enhanced compassion video OTHER

Added five additional sentences to the standard introduction video. Those five sentences were compassion-focused statements. The compassionate statements added to the "enhanced compassion video" were based on the results of a recent systematic review of clinician compassionate behaviors, which found incorporating statements of support, acknowledgement, patient's perspective, emotion naming, and validation increased patient perception of compassion.

Enhanced compassion video

Standard introduction video OTHER

Standard introduction video sent to a new patient via email introducing the new patient to the cancer center prior to the initial consultation.

Standard introduction video

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years
• scheduled for an initial oncology consultation

You may not qualify if:

• patients who do not have an active email address or are medically unable to complete the research questionnaire at the time of the initial cancer consultation.

Sponsors & Collaborators

• The Cooper Health System: lead

Study Sites (1)

Cooper University Health Care

Camden, New Jersey, 08103, United States

Location

Related Publications (2)

• Winn C, Grana G, Mazzarelli A, Nicholson A, Mykulowycz K, Obiakor C, Bair A, Trzeciak S, Roberts B. Preconsultation compassion video to reduce anxiety among patients referred to a cancer centre: a randomised control trial. BMJ Oncol. 2024 Aug 6;3(1):e000427. doi: 10.1136/bmjonc-2024-000427. eCollection 2024.

  PMID: 39886127 DERIVED

• Winn C, Generosa G, Mazzarelli A, Trzeciak S, Roberts BW. Preconsultation compassion intervention to reduce anxiety among patients referred to a cancer center: protocol for a randomised control trial. BMJ Open. 2021 May 24;11(5):e048201. doi: 10.1136/bmjopen-2020-048201.

  PMID: 34031118 DERIVED

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Brian Roberts
• Organization: Cooper University Health Care

roberts-brian-w@cooperhealth.edu

856-342-2352

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 7, 2020
• Study Start: June 1, 2021
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: November 21, 2024
• Results First Posted: November 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

US (1)