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N/A Completed N=48 Randomized Supportive Care

REVITALIZE: A Telehealth Intervention for Women With Advanced Ovarian Cancer and PARP Inhibitor-Related Fatigue

Ovarian Cancer · Fatigue · Coping Behavior · Coping Skills
Source: ClinicalTrials.gov NCT04525183 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: Fatigue Interference — 3.76; 3.52; 2.80; 2.56 score on a scale (describing the units)

Summary

This study is testing whether a 6 week skills-based telehealth intervention can help ovarian cancer patients experiencing PARP inhibitor-related fatigue reduce the impact of fatigue on their daily life and activities.

Outcome Measures

OutcomeResultp-value
PRIMARY
Fatigue Interference		 3.76; 3.52; 2.80; 2.56; 2.73; 2.43 —
PRIMARY
Fatigue Severity		 5.03; 5.05; 3.88; 4.36; 4.06; 4.16 —
PRIMARY
Current Fatigue		 4.52; 4.52; 3.48; 4.33; 4.04; 4.00 —
SECONDARY
Emotional Distress: Anxiety Symptoms		 5.84; 5.85; 5.51; 4.12; 6.14; 3.94 —
SECONDARY
Fear of Cancer Recurrence		 88.2; 83.6; 81.5; 72.9; 81.0; 74.0 —
SECONDARY
Participant Quality of Life		 60.39; 60.76; 64.09; 64.15; 63.30; 66.37 —
SECONDARY
Emotional Distress: Depressive Symptoms		 7.14; 7.14; 6.17; 4.60; 6.13; 4.27 —

Eligibility Criteria

Inclusion Criteria

  • Women ≥18 years of age who have been diagnosed with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
  • Receiving PARPI inhibitors for ≥ 2 months.
  • Able to read/speak English.
  • Have an Eastern Oncology Group (ECOG) performance of 0-2.
  • Report moderate-severe fatigue in the past week (average score ≥4 on a Fatigue Symptom Inventory scale of 0-10)

Exclusion Criteria

  • Patients with an untreated clinical condition or comorbid illness (e.g. anemia, hypothyroidism) that could explain their fatigue.
  • Patients with chronic severe fatigue that pre-dates their use of PARPi.
  • The following special populations will be excluded from this research:
  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04525183). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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