Development of a Measure of Health-Related Quality of Life for Non-Hodgkin’s Lymphoma Clinical Research: The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym).

Abstract

Background: The FACT-Lym was developed to address the disease-specific quality-of-life (QOL) issues for patients with non-Hodgkin’s lymphoma (NHL). Methods: Items for inclusion in the lymphoma subscale for the FACT instrument were generated from interviews with health care providers and published literature on NHL. Items were selected based on symptom relevance, disease-specificity and clinical relevance. Validation testing was conducted with NHL patients. Patients completed the FACT-Lym and other measures at three timepoints: baseline (T1), 3–7 days (T2), and 8–12 weeks (T3). These patients were also interviewed about item content. Results: From a pool of 69 items, 22 items were selected for testing based on relevance ratings of 17 experts. Items included B symptoms, sleep disturbance, anorexia, pruritus, pain, swelling, dyspnea, fatigue, emotional lability, worries, and uncertainty about the future. 75 NHL patients participated in validation testing (55% female, 59% with indolent disease, and 84% currently receiving treatment). Patient interviews confirmed item relevance and comprehensiveness. Item correlations, expert relevancy ratings, and patient input further reduced the subscale to 15 items. Internal consistency coefficients (alpha) for the 15–item subscale (.80, .86, .83) and test-retest stability (.85) suggest very good reliability. Correlations between the subscale and the SF-36 physical (r=.62) and mental (r=.47) summary scores reflect concurrent validity. Responsiveness to ECOG performance status rating and treatment status (on vs. off) equaled or exceeded that of the more established FACT subscale scores. From T1 to T3, subscale scores declined (−6.8, effect size= −0.86) in 14 patients who reported themselves as worsened, increased (3.9, effect size= 0.49) in 28 patients who reported themselves as improved, and did not change (−0.2, effect size= −0.02) in 18 patients who reported themselves as unchanged. Conclusions: The FACT-Lym addresses QOL concerns that are relevant to NHL patients and is reliable and valid for use in clinical research.

International development of four EORTC disease-specific quality of life questionnaires for patients with Hodgkin lymphoma, high- and low-grade non-Hodgkin lymphoma and chronic lymphocytic leukaemia

“…Nevertheless, the phase 3 modules already receive a lot of attention as in recent years the treatment of patients with lymphoproliferative disorders has changed dramatically while at the same time international recommendations are advocating more research into the QoL of these patients [ 8 – 12 ]. The only other lymphoma questionnaire that currently exists is the Fact-Lym, that includes 15 lymphoma-specific items [ 21 ]. However, certain issues that we identified as relevant (e.g.…”

“…The FACT-Lymphoma questionnaire has been developed more than a decade ago to assess QoL in the broad group of all subtypes of lymphoma cancer patients. From a pool of 69 items, following expert relevancy ratings ( n = 17), patient input ( n = 75) and item correlations, a lymphoma subscale of 15 items was constructed [ 21 ]. This questionnaire covers some, but not all issues that are sometimes only relevant to subtypes of lymphoma patients (e.g.…”

Phase I/II trial of vorinostat with rituximab, cyclophosphamide, etoposide and prednisone as palliative treatment for elderly patients with relapsed or refractory diffuse large B‐cell lymphoma not eligible for autologous stem cell transplantation

“…Response was determined according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al , ). Quality of life (QoL) was measured by the Functional Assessment of Cancer Therapy ‐ Lymphoma (FACT‐Lym) (Cella et al , ; http://www.facit.org) prior to treatment, on the first day of each treatment cycle and every 3 months during follow‐up visits for the first year after treatment. FACT‐Lym is a validated QoL instrument which adds 15 lymphoma‐specific questions to 27 questions in the FACT‐G scale (Physical Well‐Being 7, Social/Family Well‐Being 7, Emotional Well‐Being 6, Functional Well‐Being 7).…”

Testing the validity and responsiveness of a new cancer-specific health utility measure (FACT-8D) in relapsed/refractory mantle cell lymphoma, and comparison to EQ-5D-5L

“…The current version contains 27 items measuring HRQOL in four domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Extensions of the instrument have been developed for use in specific forms of cancer, including one for use in patients with non-Hodgkin's lymphoma, called the FACT-Lym [12]. The eight items composing the FACT-8D are all drawn from the FACT-G and none are specific to lymphoma patients.…”